Safety Study of Aqueous Suppression After Ahmed Glaucoma Valve (AGV) Implantation

Phase 2

• Conditions: Hypertensive Phase
• Interventions: Drug: placebo; Drug: Timolol-trusopt

• Registration Number: NCT01814514
• Lead Sponsor: Zahra Rabbani Khah

Brief Summary

The AGV implant is designed to open when the IOP is between 8 mmHg and 10 mmHg, and thus maintains an IOP of 8 mmHg or higher. In the early period after glaucoma drainage device (GDD) surgery the intraocular pressure (IOP) classically goes through 2 phases. The hypotensive phase occurs immediately after surgery, lasts around 1 week. This is followed by the hypertensive period where the IOP tends to rise steadily above 21mmhg.

The hypertensive response seems to occur more commonly after Ahmed GDD surgery than nonvalved implants, It was reported to occur in 40% to 80% of cases. Although the hypertensive phase can last as long as 6 months it is usually during the first 1 to 4 weeks, when there is intense congestion of the bleb wall, that IOP is highest.

Previous study showed that when aqueous comes into contact with conjunctiva and Tenon's capsule,an inflammatory reaction occurs.Factors such as prostaglandins, eicosanoids, tissue growth factor beta (TGF β)has been shown to occur in glaucomatous aqueous. These mediators induce an inflammatory reaction, and if excessive, will result in fibrosis and poor functioning of the bleb. High pressure within the bleb also results in the secretion of TGF β by the bleb lining. It may result in inflammation of the bleb wall and subsequent fibrosis and poor bleb function. The investigators supposed that with early use of aqueous suppressant medication after AGV implantation, the concentration of inflammatory mediators decreased in subconjunctival space and may lead to better IOP control after shunt surgery.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Status Verified: 2013-03
• Primary Completion: 2013-03
• Study First Submitted: 2013-03-07
• Study First Submitted QC: 2013-03-19
• Last Update Submitted: 2013-03-19
• Study First Posted: 2013-03-20
• Last Update Posted: 2013-03-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 94

Inclusion Criteria

• patients with uncontrolled glaucoma requiring AGV device implantation.

Exclusion Criteria

1. History of AGV implantation
2. Allergy to Anti glaucoma medication
3. unable to come for follow up
4. Known contraindication to beta blacker such as asthma- chronic obstructive pulmonary disease (COPD). Heart failure heart block
5. Learning difficulty- mental illness or severely ill

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo,Artificial tear	placebo	dosage:one drop/12 hours,duration:3 months
Timolol-trusopt	Timolol-trusopt	Dosage:One drop/12hours,duration:3 months

Primary Outcome Measures

Name	Time	Method
intraocular pressure-hypertensive phase success rate	during first 3 months	during first 3 months

Secondary Outcome Measures

Name	Time	Method
intraocular pressure success rate	after 12 months	after 12 months

Trial Locations

Locations (1)

Labbafinejad medical center; 🇮🇷 Tehran, Iran, Islamic Republic of